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A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04100616
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

Study Description
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Brief Summary:
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding obesity.

Condition or disease Intervention/treatment
Overweight and Obesity Overweight or Obesity Obesity Obesity, Morbid Obesity, Abdominal Obesity; Familial Obesity; Endocrine Obesity, Visceral Obesity Hypoventilation Syndrome Other: No intervention

Detailed Description:
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records, particularly regarding obesity.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obesity
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : July 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
Obsese individuals
Patients with a BMI greater than or equal to 30
 Other: No intervention
There is no intervention for this study


Outcome Measures
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Primary Outcome Measures :
  1. Correlation of Microbiome to Obesity via Relative Abundance Found in Microbiome Sequencing [ Time Frame: 1 year ]
    Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among obesity types


Secondary Outcome Measures :
  1. Validation of Sequencing Methods [ Time Frame: 1 year ]
    To validate the methods used to sequence samples


Biospecimen Retention:   Samples With DNA
Stool from patients.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults 18 years of age and older with a BMI greater than or equal to 30
Criteria

Inclusion Criteria:

  1. Signed informed consent by patient
  2. Male or female patients age 18 and older.
  3. Diagnosis of obesity based on Body Mass Index (BMI) of 30 or greater.

Exclusion Criteria:

  1. Refusal by patient to sign informed consent form
  2. Treatment with antibiotics within two weeks prior to screening
  3. Treatment with probiotics within six weeks prior to screening
  4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy
  5. Postoperative stoma, ostomy, or ileoanal pouch
  6. Participation in any experimental drug protocol within the past 12 weeks
  7. Treatment with total parenteral nutrition
  8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
  9. Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04100616


Contacts
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Contact: Sabine Hazan, MD 18053390549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 18053390549 jordan@progenabiome.com

Locations
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United States, California
ProgenaBiome Recruiting
Ventura, California, United States, 93003
Contact: Sabine Hazan, MD    805-339-0549    drsabinehazan@progenabiome.com   
Contact: Jordan Daniels, MS    805-339-0549    jordan@progenabiome.com   
Principal Investigator: Sabine Hazan, MD         
Sponsors and Collaborators
ProgenaBiome
Investigators
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Principal Investigator: Sabine Hazan, MD ProgenaBiome
More Information
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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04100616    
Other Study ID Numbers: PRG-005
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Only aggregated, deidentified data will be made available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoventilation
Obesity Hypoventilation Syndrome
Obesity
Obesity, Morbid
Obesity, Abdominal
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Respiratory Insufficiency
 Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases